Kornimate/medical-research-clean huggingface dataset:
miniject in patients with open angle glaucoma using single operator delivery tool

Conditions: Glaucoma, Open-Angle; Glaucoma Eye

Summary: study to assess safety and performance of miniject so627 in patients with open angle glaucoma.

the study will evaluate the efficacy and safety of mini so627 and iop (intra- ocular pressure) lowering effects with or without the use of glaucoma medications. the procedure will be a stand alone surgery. patient follow up with several examinations up to 24 months after surgery. the primary endpoint is the reduction in medicated mean diurnal iop at 6 months follow up compared to medicated diurnal iop at baseline visit.

Eligibility criteria:
inclusion criteria: * diagnosis of primary or secondary open angle glaucoma during screening/baseline visit or earlier. * grade 3 or grade 4 according to shaffer angle grading system. * glaucoma not adequately controlled by one to four different topical hypotensive medication(s), given each for at least one month, as confirmed by 21mmhg \< iop \< 35 mmhg in the study eye at baseline visit. exclusion criteria: * grade 2 (narrow, 20 degrees), grade 1 (extremely narrow, less or equal to 10 degrees) and grade 0 (closed or slit) according to shaffer angle grading system in the study eye. * neovascular glaucoma in the study eye. * corneal opacity or iridocorneal angle not visible through gonioprism in the study eye, preventing correct placement of the implant in the stud eye. * prior glaucoma surgery in the study eye.

Keywords: glaucoma medical device migs drainage device eye reduction iop
personalized treatments for depressive symptoms in patients with advanced heart failure

Conditions: Depression; Heart Failure

Summary: we are doing this study to help patients, caregivers, and providers make decisions about how best to manage depressive symptoms in advanced heart failure. there are two evidence-based treatment approaches to treating depression in patients with advanced heart failure, behavioral action psychotherapy and treatment with anti-depressant medications. in this study we want to compare the effectiveness of these two treatment options to learn which treatment works better.

aim 1: to compare the effectiveness of ba vs. meds, for depressed ahf patients. hypothesis 1: compared to depressed ahf patients who receive meds, patients receiving ba will have significantly greater improvements in the primary outcome of depressive symptom severity as measured with the phq-9 at 6-month follow-up. significantly greater improvements will also be detected in the secondary outcomes of general physical and mental hrqol (sf-12v2), heart failure-specific hrqol (kccq), and caregiver burden (cbq-hf) at 3, 6, and 12 months. aim 2: to compare the impact of ba vs. meds on disadvantageous outcomes of morbidity (as evidenced by ed visits, hospital readmissions, total days in the hospital), and mortality among depressed ahf patients. hypothesis 2: compared to depressed ahf patients who receive meds, those receiving ba will have significantly less morbidity (as evidenced by less frequent ed visits, lower readmission rates, fewer total days in the hospital), and reduced mortality at the data collection points of 3, 6, and 12 months.

Eligibility criteria:
inclusion criteria: 1. hf new york heart association classes: ii-iv. 2. life expectancy of more than 6 months. 3. phq-9 score ≥10. 4. diagnosis of major depressive disorder, persistent depressive disorder (dysthymia), and depressive disorder unspecified, as confirmed by the mini 7.02. exclusion criteria: 1. imminent danger to self or others. 2. cognitive impairments with a moca score of \< 23. 3. bipolar, psychotic, and substance-induced disorders. 4. patients in active treatment of depression who are already on antidepressants, psychotherapy, or both.
assessment of psychological symptoms among fibromyalgia patients

Conditions: Psychological Symptoms in Fibromyalgia Patients

Summary: fibromyalgia is a syndrome characterized by chronic widespread pain at multiple tender points, joint stiffness, and systemic symptoms (e.g., mood disorders, fatigue, cognitive dysfunction, and insomnia) \[14\] without a well-defined underlying organic disease. nevertheless, it can be associated with specific diseases such as rheumatic pathologies, psychiatric or neurological disorders, infections, and diabetes. the prevalence of fibromyalgia has been estimated to be around 1%-2% (3.4% for women and 0.5% for men) \[5, 6\].

the etiology and pathogenesis of fibromyalgia are still not fully understood. several factors such as dysfunction of the central and autonomic nervous systems, neurotransmitters, hormones, immune system, external stressors, psychiatric aspects, and others seem to be involved. diagnosis is principally based on the two major diagnostic criteria defined by the acr in 1990 \[7\]: (1) a history of widespread musculoskeletal pain present for at least three months, and (2) tenderness in at least 11 of 18 defined tender points psychiatric problems seem to contribute considerably to the development of fibromyalgia. the prevalence of psychiatric conditions among patients affected by fibromyalgia is higher than among subjects complaining of other rheumatic diseases . the most common disorders associated are anxiety, somatization, dysthymia, panic disorders, posttraumatic stress, and overall depression \[8\]. depression is more frequently associated with fibromyalgia than with other musculoskeletal diseases \[9\] depression worsens fibromyalgic symptoms and vice versa, and antidepressants represent a cornerstone of fibromyalgia therapy \[1011\]. over the last decade, it has been repeatedly shown that noninvasive repetitive transcranial magnetic stimulation (rtms) of the primary motor cortex (m1) induces analgesic effects both in experimental pain \[1216\] , probably by activating pain modulation systems. another way studied to relieve fibromyalgia pain is sphenopalatine ganglion block in our study we will evaluate the effect of repetitive transcranial magnetic stimulation and sphenopalatine ganglion block on fibromyalgia pain and psychiatric symptoms. rtms will be applied on primary motor area (m1) for 20 sessions (5 daily per week for 4 weeks)with 20 hz and 3000pul with evaluation of pain and psychological symptoms befor intervention and after 10 sesions and after 1 month of last session compared to sphenopalatine ganglion block effect .

Eligibility criteria:
inclusion criteria: - women aged from 18 to 60 years old diagnosed as fibromyalgia with resistence to pharmacological treatment exclusion criteria: * previous psychiatric disorders sever cognitive dysfunction other medical or neurological disorders pregnant females
a study of incb050465 in combination with ruxolitinib in subjects with myelofibrosis

Conditions: MPN (Myeloproliferative Neoplasms)

Summary: the purpose of this study is to evaluate the safety, tolerability, and efficacy of the combination of parsaclisib and ruxolitinib in subjects with myelofibrosis.


Eligibility criteria:
inclusion criteria: * diagnosis of primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis * palpable spleen of \> 10 cm below the left subcostal margin on physical examination at the screening visit or * palpable splenomegaly of 5 to 10 cm below left subcostal margin on physical exam and active symptoms of mf at the screening visit as demonstrated by presence of 1 symptom score ≥ 5 or 2 symptom scores ≥ 3 using the screening symptom form * eastern cooperative oncology group (ecog) performance status of 0, 1, or 2 exclusion criteria: * use of experimental drug therapy for myelofibrosis, or any other standard drug (eg, danazol, hydroxyurea, etc) with the exception of ruxolitinib within 6 months of starting study (combination) therapy and/or lack of recovery from all toxicities from previous therapy (except ruxolitinib) to grade 1 or better * inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications * unwillingness to be transfused with blood components * recent history of inadequate bone marrow reserve as demonstrated by the following: * platelet count \< 50 × 10\^9/l in the 4 weeks before screening or platelet transfusion(s) within 8 weeks before screening * absolute neutrophil count levels \< 0.5 × 10\^9/l in the 4 weeks before screening * subjects with peripheral blood blast count of \> 10% at the screening or baseline hematology assessments * subjects who are not willing to receive red blood cell (rbc) transfusions to treat low hemoglobin levels * inadequate liver function at screening as demonstrated by the following: * direct bilirubin ≥ 2.0 × the upper limit of laboratory normal (uln). (note: direct bilirubin will only be determined if total bilirubin is ≥ 2.0 × uln) * alanine aminotransferase (alt) or aspartate aminotransferase (ast) \> 2.5 × uln * inadequate renal function at screening as demonstrated by creatinine clearance \< 50 ml/min or glomerular filtration rate \< 50 ml/min/1.73 m\^2

Keywords: primary myelofibrosis (pmf) post-polycythemia vera myelofibrosis (ppv-mf) post-essential thrombocythemia myelofibrosis (pet-mf) myeloproliferative neoplasms (mpns) phosphoinositide 3-kinase (pi3k) inhibitor janus kinase (jak) inhibitor
interest of a highly cross-linked polyethylene acetabular component doped with vitamin e in total hip arthroplasty of the young and active subject

Conditions: Hip Arthropathy

Summary: interest of a highly cross-linked polyethylene acetabular component doped with vitamin e in total hip arthroplasty of the young and active subject.

a single-centre, prospective, randomised, single-blind, comparative study of two parallel groups of patients undergoing total hip arthroplasty: * group 1: prosthesis with a second-generation ceramic-on-highly cross-linked polyethylene (copxe) couple. * group 2: prosthesis with ceramic-on-ceramic (coc) torque.

Eligibility criteria:
inclusion criteria: * patient aged 18 to 65 years, * who have signed their consent to participate in the study, * for whom an indication for total hip arthroplasty has been given exclusion criteria: * history of hip surgery * indication for a dual mobility prosthesis (obese patient, dynamic spino-pelvic anomaly) * hip dysplasia * inflammatory rheumatic disease or any other progressive concomitant condition that may impact the patient's vital or functional prognosis * sequelae of neurological disease or stroke * pregnant or breastfeeding women * mental deficiency or any other reason that may hinder the understanding or the strict application of the protocol * patient likely not to return for follow-up visits * patient already included in another therapeutic study protocol * patient under court protection, guardianship or curatorship.
mhealth for prep adherence by young adult msm, phase 2

Conditions: Hiv

Summary: this phase 2 project aims to enhance and test a mobile health intervention designed to increase adherence to the daily prep pill among culturally-diverse young adult men who have sex with men. the intervention will include: a) personalized prep pill reminders b) culturally- and developmentally-sensitive text messages targeting patient education, motivation, and stress c) a gamification avatar and d) a linked online community of peers. effectively promoting prep adherence would reduce new hiv infections in this at-risk population, which is subject to health disparities

the project is to develop and test the effectiveness of an individually-tailored, developmentally- and culturally-sensitive, mobile health (mhealth) prep adherence intervention called dot. the intervention will target culturally-diverse, young adult men, ages 18-35, who have sex with men (ymsm). the recent rise in hiv infection among young people, particularly minority ymsm, points to the value of prep uptake and adherence support for ymsm. in prep efficacy trials, younger age was the most consistent correlate with low prep adherence. our dot mhealth intervention reflects a developmental understanding of young adult decision-making, and is uniquely combined with principles from social cognitive theory, positive psychology and behavioral economics. the proposed project is based on dr. weitzman's successful phase 1 trial of dot, which led to significant improvements in prep adherence, prep treatment self-efficacy, and intention to follow prep treatment guidelines among the ymsm that used dot for six weeks. our proposed phase 2 dot mhealth intervention is directly responsive to phase 1 findings by adding: 1) texts targeting motivation, patient education, and stress burden 2) online community for social support 3) linkage to the federal crisis text line 4) virtual avatar 5) cloud-based platform to view user engagement 7) calendar for clinic appointments and pharmacy refills 8) enhanced personalization of pill reminders and 9) enhanced adherence graphing. in phase 2, we will test the effectiveness of dot at improving prep adherence in a randomized controlled trial.

Eligibility criteria:
inclusion criteria: (self report) individuals who self-identify as a male, age 18-35, who has sex with men or who self-identify as a bisexual male or a gay male; currently taking prep; own a smartphone and desirous of adherence support. - exclusion criteria: (self report) males who do not meet the above criteria and/or currently use i.v. drugs.
study of ixekizumab (ly2439821) in children 6 to less than 18 years with moderate-to-severe plaque psoriasis

Conditions: Plaque Psoriasis

Summary: the purpose of this study is to evaluate the safety and efficacy of ixekizumab in pediatric participants with moderate-to-severe plaque psoriasis.


Eligibility criteria:
inclusion criteria: * have a diagnosis of moderate-to-severe plaque-type psoriasis for at least 6 months prior to baseline as determined by the investigator. * have psoriasis area and severity index (pasi) score ≥12 and a static physician global assessment (spga) ≥3 and body surface area involvement ≥10% at screening and baseline. * are candidates for phototherapy or systemic treatment or considered by the investigator as not adequately controlled by topical therapies. * male subjects agree to use a reliable method of birth control during the study. * female subjects: participants of childbearing age or childbearing potential who are sexually active who test negative for pregnancy must be counselled and agree to use either 1 highly effective method of contraception or 2 acceptable methods of contraception combined for the duration of the study and for at least 12 weeks following the last dose of study drug, or remain abstinent during the study and for at least 12 weeks following the last dose of study drug. * both the child or adolescent and a parent or legal guardian are able to understand and fully participate in the activities of the clinical study and sign their assent and consent, respectively. * all immunizations are up-to-date in agreement with current immunization guidelines as noted by country specific paediatric authorities (e.g., the american academy of paediatrics). note, subjects who are not up to date or have never been immunized are not to be enrolled in the trial. exclusion criteria: * have pustular, erythrodermic, and/or guttate forms of psoriasis. * have drug-induced psoriasis. * have clinical and/or laboratory evidence of untreated latent or active tuberculosis (tb). * participants with a documented history of immune deficiency syndrome. * have any other active or recent infection, including chronic or localized infections, within 4 weeks of baseline. * subjects with a known history of malignancy, lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly unless ruled out by biopsy. * have used any therapeutic agent targeted at reducing interleukin-17. * have received other therapies within the specified time frames prior to screening (see below): * adalimumab and infliximab 60 days, abatacept 90 days, anakinra 7 days, or any other biologic disease-modifying antirheumatic drug 5 half-lives. * systemic therapy for psoriasis and psoriatic arthritis (psa) (other than above, eg, methotrexate, cyclosporine), phototherapy (eg, photochemotherapy \[psoralen plus ultraviolet a\]) in the previous 4 weeks.

Keywords: children psoriasis treatment adolescents
brief intervention to prevent poor psychosocial outcomes in living donors

Conditions: Living Donation

Summary: the purpose of this study is to evaluate the potential effectiveness of a psychosocial intervention based on the principles of motivational interviewing. the novel intervention will assist living donor candidates to think through any remaining concerns or questions that they may have about living donation. if the intervention is effective, it may help to prevent post-donation problems related to psychological and health outcomes.

the protection of living donors' well-being and the prevention of any negative consequences of donation are among the foremost priorities in transplantation. some donors experience poor psychosocial outcomes after donation, including psychological distress, poor perceived physical well-being, and strained family relationships. no preventive interventions have been mounted or tested for their ability to avert poor psychosocial outcomes in living donors. the present study will provide an initial test of a new intervention for this purpose. the new intervention utilizes motivational interviewing (mi) to address remaining concerns that individuals may have about proceeding with living donation. study participants will be randomly assigned to either (a) participate in the mi intervention (during which they will be asked to answer a series of questions to help them better delineate their reasons for and against proceeding with living organ donation), (b) participate in a comparison intervention designed to inform them about healthy lifestyle habits, or (c) not receive any intervention. we plan to recruit a maximum of 150 adults who are considering whether to serve as living kidney or liver donors. we hypothesize that participants receiving the mi intervention will have superior outcomes (less psychological distress, fewer physical health complaints, better interpersonal relationships within their family, better overall quality of life)after donation.

Eligibility criteria:
inclusion criteria: * score of 1 or greater on the simmons ambivalence scale; * must be able to speak english; * have been evaluated as a potential living kidney or liver donor candidate; * aged 18 or older

Keywords: living donation organ donation psychological adaptation mental health physical well-being interpersonal relations quality of life psychosocial factors
prospective evaluation of a fast-track treatment pathway for patients with chronic hepatitis b under primary care

Conditions: Chronic Hep B

Summary: this is a retrospective-prospective longitudinal cohort study, with analyses performed before and after introduction of the pathway, and comparisons made to unexposed controls. we will launch a protocol-driven management for chb patients, and provide the appropriate assessment tools (transient elastography, hbv dna assay) to general outpatient clinics (gopc) in hong kong. patients who fulfil treatment criteria will be referred to specialist outpatient clinics (sopc) in a fast-track manner. we will also evaluate the linkage-to-care rate 3 years before the launch of this care pathway retrospectively.

chronic viral hepatitis is the seventh leading cause of mortality globally, responsible for 1.45 million deaths in 2013. the consequences of chronic hepatitis b and c infection - cirrhosis and liver cancer - account for 94% of deaths associated with hepatitis.1 liver cancer is the second most common cause of cancer death in the asia-pacific region. approximately 78% of liver cancer cases are a result of chronic viral hepatitis.1,2 in hong kong, the positive rate of hepatitis b surface antigen (hbsag) remains high among adults of productive ages of 31-40 and 41-50 years (5.2% and 7.2% respectively) in 2015.3 world health organization (who) published the first global health sector strategy on viral hepatitis in june 2016, a strategy that contributes to the proposed targets for the reduction of chronic viral hepatitis incidence and mortality of 90% and 65% respectively by 2030.4 the chief executive's 2017 policy address in hong kong asked to set up the steering committee to formulate strategies to effectively prevent and control viral hepatitis.5 the steering committee is currently reviewing local and international trends and developments in the prevention and control of viral hepatitis; advising the government on policies and cost-effective targeted strategies for prevention and control of viral hepatitis; and conducting and coordinating the surveillance and evaluation of viral hepatitis control and recommending appropriate response.5 one of the key gaps in chb management is the suboptimal treatment in patients who fulfil treatment criteria but not started on antiviral treatment because of linkage-to-care issue, namely very long waiting time (up to 2.5 years) from primary care setting like general outpatient clinics (gopc). there are limited resources for specialized assessments (e.g. hbv dna assays, transient elastography for liver fibrosis assessment). therefore a novel fast-track treatment pathway for patients with chronic hepatitis b under primary care would fill this gap and provide pivotal data to the government and the steering committee to guide the strategies for achieving the goals set by who.

Eligibility criteria:
inclusion criteria: * adult patients with positive hepatitis b surface antigen (hbsag) for 6 months * under the care of gopc exclusion criteria: * age under 18 * refusal to consent
blood collection to validated new therapeutics strategies against preeclampsia

Conditions: Preeclampsia

Summary: the aim of the study is to setup a collection of maternal plasma and serum from patients with preeclampsia and normal pregnancy for in vitro validation of new therapeutics based on extra-corporal removal of sflt-1

a collection of maternal plasma and serum from patients with preeclampsia (pe) and normal pregnancy (np) : * between 20wg and 23wg+6d : 20 patients with pe and 30 patients with np * between 24wg and 27wg+6d : 20 patients with pe and 30 patients with np * between 28wg and 31wg+6d : 20 patients with pe and 30 patients with np * between 32wg and 35wg+6d : 20 patients with pe and 30 patients with np * between 36wg and 40wg+6d : 20 patients with pe and 30 patients with np

Eligibility criteria:
inclusion criteria: * age from 18 to 50 years old * singleton pregnancies between 20 and 41 weeks of gestation * preeclampsia * normal pregnancy exclusion criteria: * age\<18 * infectious disease: hiv, hbv or hcv * multiple pregnancies * opposition of the patient

Keywords: preeclampsia apheresis sflt-1